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Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: a multicenter, single-blinded, randomised controlled trial.

Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: a multicenter, single-blinded, randomised controlled trial. - EUTOPIA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047528
Enrollment
880
Registered
2022-04-20
Start date
2022-05-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreaticobiliary disease

Interventions

ice water group ERCP will be performed, and at the end of the procedure, ice water will be injected on the duodenal papilla. A total of 250 ml is injected five times with a 50 ml syringe. The water

Sponsors

Kitano Hospital, Tazuke Kofukai Medical Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria are applied to patients who were scheduled to undergo an ERCP.

Exclusion criteria

Exclusion criteria: (1) evaluated 4 levels according to the Eastern Cooperative Oncology Group Performance Status (2) age younger than 20 years (3) not native papilla (4) those cases that were expected to have duodenal papilla that were inaccessible by endoscopy (5) case of post gastrectomy (excluding B-I reconstruction) (6)presence of acute pancreatitis (7) presence of chronic pancreatitis (8) presence of pancreatic head cancer with occlusion of the main pancreatic duct (9)inability to provide written informed consent (10)subjects deemed inappropriate for the trial

Design outcomes

Primary

MeasureTime frame
PEP incidence

Secondary

MeasureTime frame
(1) Incidence of PEP in patients with difficult bile duct or pancreatic duct intubation, (2) Incidence of PEP by various ERCP procedures (bile duct purpose, pancreatic duct purpose, EST, EPBD, biopsy, IDUS, bile duct stenting, etc.), (3) Incidence of PEP by presence or absence of pancreatic duct cannulation or pancreatography, (4) Incidence of PEP by cannulation time, ( (5) Severity of PEP, (6) Incidence of PEP by high risk factors for PEP, (7) Incidence of other complications

Countries

Japan

Contacts

Public ContactShunjiro Azuma

Kitano Hospital, Tazuke Kofukai Medical Research Institute Department of Gastroenterology and Hepatology

s-azuma@kitano-hp.or.jp06-6312-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026